The Combination of Ribavirin and Peginterferon Is Superior to Peginterferon and Placebo for Children and Adolescents With Chronic Hepatitis C　（子供青年についてもペグインターフェロン単独よりもリバビリン併用療法はよい）

2011年1月28日2011年1月30日日記

GastroenterologyVolume 140, Issue 2 , Pages 450-458.e1, February 2011

に、つい、大人も子供も治療は同じと考え易い点について、きちんと実証した論文が掲載されました。

こんにちは。　千葉県　木更津市　はやさかクリニック　院長　肝臓専門医　早坂章です。

この記事の内容が皆様のお役にたてることを願っています。

以下、英文ですが、引用です。結論として、C型肝炎治療において子供青年についてもペグインターフェロン単独よりもリバビリン併用療法はよい、とのことだと思います。

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1. Background & Aims
2. Methods
3. Results
4. Conclusions

Background & Aims

Although randomized trials of adults infected with hepatitis C virus (HCV) have shown that ribavirin increases the efficacy of pegylated interferon (PEG), such trials have not been performed in children. We conducted a randomized controlled trial of PEG and ribavirin, compared with PEG and placebo, in children 5 to 17 years old with chronic hepatitis C.

Methods

HCV RNA–positive children from 11 university medical centers were randomly assigned to receive either PEG alfa-2a (PEG-2a; 180 μg/1.73 m² body surface area, subcutaneously each week; n = 55) and ribavirin (15 mg/kg orally in 2 doses daily) or PEG-2a and placebo (n = 59) for 48 weeks. The primary end point was sustained virologic response (SVR; lack of detectable HCV RNA at least 24 weeks after stopping therapy).

Results

SVR was achieved in 53% of children treated with PEG-2a and ribavirin, compared with 21% of children who received PEG-2a and placebo (P < .001). Early virologic response (HCV RNA reduction >2 log₁₀ IU at 12 weeks) had a negative predictive value of only 0.89 in children with genotype 1, indicating that these children might benefit from 24 weeks of therapy before stopping treatment. Side effects, especially neutropenia, led to dose modification in 40% of children. Eighty-two percent of the PEG/ribavirin and 86% of the PEG/placebo group were in compliance with the year 2 follow-up visit; the durability of virologic response was 100% in both groups.